Part I Overview Information

Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov)

Components of Participating Organizations
National Institutes of Environmental Health Sciences (NIEHS), (http://www.niehs.nih.gov)

Title: Advanced Research Cooperation in Environmental Health Research

Announcement Type
This is a re-issue of RFA-ES-04-006, which was previously released August 15, 2004.

Request For Applications (RFA) Number: RFA-ES-05-006

Catalog of Federal Domestic Assistance Number(s)
93.113, 93.114, 93.115

Key Dates
Release Date: September 26, 2005
Letters of Intent Receipt Date(s): October 14, 2005
Application Receipt Dates(s): November 16, 2005
Peer Review Date(s): March 2006
Council Review Date(s): May 2006
Earliest Anticipated Start Date: July 1, 2006
Additional Information To Be Available Date (Url Activation Date): N/A
Expiration Date: November 17, 2005

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

Table of Contents

Part I. Overview Information

Part II. Full Text of Announcement

 Section I. Funding Opportunity Description
   1. Research Objectives

 Section II. Award Information
   1. Mechanism(s) of Support
   2. Funds Available

 Section III. Eligibility Information
   1. Eligible Applicants
     A. Eligible Institutions
     B. Eligible Individuals
   2. Cost Sharing or Matching
   3. Other - Special Eligibility Criteria

 Section IV. Application and Submission Information
   1. Address to Request Application Information
   2. Content and Form of Application Submission
   3. Submission Dates and Times
     A. Receipt, Review and Anticipated Start Dates
       1. Letter of Intent
     B. Sending an Application to the NIH
     C. Application Processing
   4. Intergovernmental Review
   5. Funding Restrictions

 Section V. Application Review Information
   1. Criteria
   2. Review and Selection Process
     A. Additional Review Criteria
     B. Additional Review Considerations
     C. Sharing Research Data
     D. Sharing Research Resources
   3. Anticipated Announcement and Award Dates

 Section VI. Award Administration Information
   1. Award Notices
   2. Administrative and National Policy Requirements
   3. Reporting

 Section VII. Agency Contact(s)
   1. Scientific/Research Contact(s)
   2. Peer Review Contact(s)
   3. Financial/ Grants Management Contact(s)

 Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description

1. Research Objectives

Purpose

The mission of the National Institute of Environmental Health Sciences (NIEHS) is to reduce the burden of human illness and dysfunction from environmental exposures. The NIEHS achieves its mission through multidisciplinary biomedical research programs, prevention and intervention efforts, and communication strategies that encompass training, education, technology transfer, and community outreach. An important element of the NIEHS mission is to develop the research capacity of minority-serving institutions that have research scientists who are committed to understanding the impact of environmental exposures on human health. To address this need, the NIEHS has developed a Thematic Program Project Grant (S11) that focuses on establishing research partnerships between investigators at Research Intensive Universities (RIUs) with significant biomedical health sciences research and at Minority Serving Institutions (MSIs) with graduate and/or professional schools conferring doctoral degrees. MSIs for the purposes of this solicitation are academic institutions, either medical or non-medical, that have a minority enrollment greater than 50 percent. This includes Historically Black Colleges and Universities (HBCUs), Hispanic Serving Institutions (HSIs), and Tribal Colleges and Universities. The purpose of this grant is to establish a research infrastructure and a hypothesis-driven research program at a Minority Serving Institute that develops a cadre of investigators that will successfully compete for Research Project Grant (RPG) support.

Goals

The ARCH grant is a mechanism for the support of a broadly based research program involving investigators at an MSI and established investigators at an RIU sharing knowledge and common resources. The goal of the ARCH grant is to establish a group of investigators at an MSI that can successfully compete for National Institutes of Health (NIH)/NIEHS Research Project Grant (RPG) support, typically R01/R15 grants, or awards from other agencies that use the peer review mechanism, for example, U.S Environmental Protection Agency, the National Science Foundation, or the American Cancer Society. To achieve this goal an ARCH grant will provide support for a broadly based multidisciplinary research program that has a well-defined central research focus or objective. Thus, as the ARCH program develops at the MSI, it is expected that the MSI investigators will compete for other types of grants in areas relevant to the NIEHS mission (K01, R15, R03, R01, P01, F31/32, T32, etc.) that will provide research support after the ARCH award support ends. Information on the mission and program interests of NIEHS is available on the web site: http://www.niehs.nih.gov/dert/programs/special/special.htm.

Essential Characteristics of ARCH Grants

Overall Characteristics

The ARCH grant will support a broadly based multidisciplinary research and development program that is a collaborative effort between an MSI and an RIU. The program focus should be on establishing a group of investigators at the MSI that can compete for NIH Research Project Grant (R03, R21, R01 or R15 if R15 eligible) support. Key factors for an ARCH grant are as follows:

There should be a unifying, well-defined goal or problem area of research to which each project relates and contributes. This may be a specific disease outcome, e.g., asthma, diabetes, cancer, low birth weight or children's health, autoimmune disorders, etc. or a more general area, such as, gene-environment interactions, xenobiotic gene regulation, molecular mechanisms of toxicity.

There must be participation of established investigators from the RIU and MSI, and all investigators must contribute to, and share the responsibilities for, fulfilling the program objectives. The program should include enough participation to make a collaborative effort successful, and yet not so diverse in scope as to make program collaboration and communication ineffective.

The RIU investigators included in this project must have significant peer-reviewed research project grant support that is relevant to the NIEHS mission (see NIEHS web site: http://www.niehs.nih.gov/external/intro.htm).

There must be a demonstrated commitment of the MSI and RIU institutions to the support and encourage the ARCH program. Such support usually involves release time of faculty, capital improvements that will facilitate the research, and assistance in the acquisition of scientific equipment and supplies. A letter of support from the Chancellor or President of the applicant institution will be required to demonstrate support for the ARCH program from the highest level of institutional administration.

All MSI ARCH investigators must spend a sabbatical period in the laboratory of their RIU collaborator. This sabbatical period must consist of a minimum of one semester and can include summer research experiences. It is anticipated that during the sabbatical period, the MSI ARCH investigator will further hone his/her research skills and write and submit a grant application under the tutelage of his/her RIU collaborator.

Administrative and Planning Core

There must be strong leaders at both the MSI and RIU who are substantially committed to the project, are capable of scientific leadership and are willing to accept responsibility for the administration and integration of the program. Assessment of the ability of the program Principal Investigator (ARCH Director) and RIU leader to develop a tightly integrated program of collaborative research will be a significant consideration in evaluation of the application.

The administrative/planning core must provide the support of administrative and research development infrastructure for the entire program and should not be duplicated within any other components or within support normally provided by the MSI or RIU institutions. The responsibilities and activities for the administrative and planning core include:

Appropriate and adequate organization and facilities for conduct of the research and development activities such as seminars, workshops, reference collection, computer support, etc. Specifically the administration and planning core must develop and support a grants writing course (not a seminar) that is available to all MSI ARCH grant investigators and other MSI faculty. Additionally this core must also subscribe and provide access to electronic library services that allow MSI ARCH grant investigators to remain current with scientific literature relevant to their research pursuits.

An Internal Steering Committee formed of the individual project leaders (RIU and MSI investigators) that will assist the Principal Investigator in making scientific and administrative decisions in the operation of the program.

An External Advisory Committee, comprised of at least three members who are outside both the MIU and RIU and are recognized leaders in the biomedical sciences related to the scientific theme of the program, that will provide overall guidance and advice to the Principal Investigator and program investigators on program direction.

A Senior Scientific Advisor (SSA) who is on the faculty of the MSI and has been successful in attracting RPGs (R01, P01, etc.) from the NIH. This individual will assist the ARCH Director in the overall development of the MSI research infrastructure and advise the MSI investigators on the preparation of research grant applications. The SSA must have affiliation with the MSI and serve as a liaison between ARCH grant investigators and administration.

Research Program Development Core

The function of the core is to strengthen, stabilize and consolidate interaction and cooperation between the Minority Serving Institution and the collaborating RIU's environmental health science program. All research projects will be part of the Research Development Core. Two types of projects (Pilot and Research) will be supported as part of the ARCH program and both types must be present. It is of paramount importance that each project (Pilot and Research) be of sufficient scientific merit to warrant independent support and that each project is an integral part of the ARCH program. An ARCH program must have at least three Pilot projects and one Research project that are judged to have significant and substantial scientific merit on their own.

Research projects are R01-type projects that have as the project leader either RIU or MSI faculty who have been Principal Investigators on competitive NIH R01 grant applications and/or awards in the past three years. A faculty member from the other collaborating institution is required to be included in the project. The maximum project period for a Research project is five years. One research project will be funded by an ARCH award. The roles of both the MSI and RIU collaborators must be clearly described in the ARCH grant application.

Pilot projects are intended to provide the MSI investigator an opportunity to develop his/her research skills and/or to obtain preliminary research data needed for the submission of a peer reviewed research grant application. Additionally pilot projects may provide RIU collaborators/mentors an opportunity to develop/pursue new research activities that generate preliminary data to be used in subsequent traditional grant submissions. Pilot projects can also be developed in the RIU investigators established area of research.

Pilot projects are established between an MSI investigator and an RIU mentor/collaborator. The maximum project period for a Pilot project is 36 months. Pilot project leaders may be either MSI or RIU investigators.

In order to assess the success of the pilot projects and to provide for new pilot projects, the application must include a provision for:

A. Facilities Core may be proposed provided it meets the criteria listed below:

Allowable Costs

The ARCH award will provide multiple components of support that in total will provide funds for the establishment of research and development collaboration between groups of investigators at an MSI and an RIU. The general budget categories and dollar levels that can be supported by this award are listed below. However, the specifics for each budget category are the responsibility of the Principal Investigator. The total direct cost that may be requested for an ARCH program is limited to $700,000 per year. Indirect costs for the subcontract to the RIU that are included as a part of the MSI direct costs are not included in the $700,000 per year budget limit.

A. Administrative/Planning Core

1. The ARCH grant will provide up to $150,000 (direct cost) per year for administrative/planning support. These funds are intended to support the research infrastructure necessary to provide MSI investigators an adequate opportunity to develop competitive research applications. Funds for the conduct of Pilot and Research projects including salary are to be included in the Research Program Development Core budget. The MSI Principal Investigator and the RIU leader are responsible for development of the Administrative/Planning Core budget. A listing of some of the items that may be included in this core is provided below.

Budget Item and Maximum Allowable Support:

2. An additional request of up to $100,000 for major equipment items for MSI investigators may be included in the Administrative/Planning Core budget in one of the first two years. This $100,000 is included in the $700,000 direct cost maximum and is restricted to capital equipment purchase. This equipment may be in addition to equipment that is requested for the Research/Pilot projects or the Core facility. These equipment items must be well justified and be an integral part of the research program the MSI investigator(s) plan to develop. These funds are in addition to the $150,000 for the administrative/planning core budget items identified above.

B. Research Program Development Core

The ARCH grant will provide up to $375,000 in direct costs per year for the research program development core at the ARCH to include: 1) At least three collaborative pilot projects between ARCH (MSI and RIU) investigators; and 2) one collaborative Research project between MSI and RIU investigators [most likely will be at RIU] [Describe Facility Cores separately from the Research Program Development Core].

1. Pilot Projects

Items that may be included are MSI and RIU investigator salaries, technical support, supplies, small equipment items, travel and other items that are necessary for the conduct of the Pilot Project. The maximum direct cost for each Pilot Project is $50,000 per 12-month period, and the maximum length of a Pilot Project is 36 months. At least three Pilot Projects must be recommended by the Special Emphasis Panel (SEP) in order to be eligible for an ARCH award. Pilot Projects may be located on either the MSI or RIU campus and each Pilot Project will be a collaborative effort between MSI and RIU investigators.

2. Research Projects

Research Projects are to be conducted by RIU and MSI investigators. The maximum direct cost for a Research Project is $125,000 per year, and funding may be requested for up to five years. One Research Project will be supported per ARCH award.

C. Facility Core

The Principal Investigator may request up to $100,000 per year (direct cost) for the Facility Core.

The Facility Core unit is a resource for the Research/Pilot projects that provides centralized services or equipment to several projects. At a minimum, a Facility Core must provide service or equipment for at least one Pilot Project and one Research Project. The Facility Core must be located at the MSI and the support may be directed to different component research projects as the scientific program advances.

The ARCH program is not intended to provide support for graduate students. Such support should be obtained through competitive training programs of the NIH/NIEHS such as the Individual (F31), Institutional (T32) National Research Service Awards or through supplements to ongoing RPGs.

D. Supplemental Funds for Additional MSI Investigators or Postdoctoral

Trainees

As the program develops, supplemental funds may be requested for support of additional MSI/RIU faculty and postdoctoral trainees on RIU Research projects. This includes Research Supplements for Underrepresented Minorities (http://grants.nih.gov/grants/guide/pa-files/PA-01-079.html) and is restricted to the RIU Research Projects. Other types of administrative supplement requests will require approval of NIEHS staff prior to submission, and is contingent upon availability of funds.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Additional Criteria

A. Pre-application Phase.

Communications between a potential Principal Investigator and program staff of the NIEHS at the pre-application planning phase will serve to (1) advise the applicant concerning the areas of program interests of the NIEHS; (2) facilitate the receipt of a well-organized, tightly-focused application; and (3) ensure that the application conforms to established guidelines and criteria for an S11 application. The initial contact with NIEHS program staff is the responsibility of the potential applicant and should be made as early as possible. This interaction may take the form of correspondence, such as a letter of intent, telephone conversations, etc. Program staff is cognizant of the scope of their programs and the S11 guidelines and are especially qualified to advise applicants concerning the preparation of a complete and well-developed application. This communication will enable the program staff to discuss issues such as the need for integration of all projects into the theme of the overall program, the established review guidelines, the proper format of the applications, and the necessary relevancy of the proposal to the programs supported by the NIEHS.

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity will use the S11 award mechanism(s). As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

This funding opportunity uses the just-in-time budget concepts. It also uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application.

2. Funds Available

The NIEHS intends to commit approximately $2,000,000 in FY 2006 to fund 2-3 new and/or competitive continuation grants in response to this RFA. An applicant may request a project period of up to 5 years and a budget for direct costs of up to $700,000 per year. Because of the nature and scope the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the NIEHS provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. Applicants that receive ARCH awards will be limited to one competitive renewal award. The anticipated earliest award date is July 1, 2006.

The NIEHS intends to commit approximately $2,000.00 dollars in FY 06 to fund 2-3 new and/or competing continuation grants in response to this RFA. An applicant may request a project period of up to 5 years and a budget for direct costs up to $700,000 dollars per year.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

You may submit (an) application(s) if your organization has any of the following characteristics:

Applicant Organization and Investigators

For this RFA the applicant organization must be a Minority Serving Institution (MSI). The MSI must have a graduate or professional school that offers at least one doctoral degree (Ph. D., M.D., D.V.M., D.D.S., etc.). The Principal Investigator must have his/her primary appointment at the applicant MSI, and have a strong interest in environmental health sciences. The ARCH application must also include a Research Intensive University (RIU) with significant research support in environmental health sciences with an RIU leader (co-investigator) who has demonstrated interests in environmental health sciences. Applications that include RIU investigators who are current NIEHS grantees are strongly encouraged but not required. Only one application will be accepted per eligible minority serving institution and the partnering research intensive university may only participate in one application responding to this solicitation.

MSI and RIU Collaboration

The MSI/RIU collaboration must be between an MSI with a strong interest in environmental health sciences and RIU investigators with a significant research base in peer reviewed environmental health sciences-related research support such as R01, P20/30, P42, etc. Environmental health has been defined as "those aspects of human health, including quality of life, that are determined by physical, chemical, biological, social and psychosocial factors in the environment (World Health Organization, 1993)." Thus, collaborations may focus on any component of environmental health science-research as defined by the preceding definition of environmental health. ARCH awards will support research that utilizes state of the art methodologies in the conduct of environmental health sciences research.

The need for continuous and active communication among sites dictates that only MSIs in the United States, its possessions or its territories are eligible to apply. Ideally, the collaborating institutions should be in close proximity to one another, less than 100 miles apart. However, if the distance between institutions exceeds 100 miles, applicants should describe procedures and/or processes that will be used to overcome any potential problems associated with the geographical separation. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. ARCH programs will: (1) help minority institutions develop state-of-the-art environmental health science research programs; (2) create more opportunities for researchers employed by minority serving institutions to establish research collaborations and professional networks with NIH grantees employed by research intensive institutions; (3) increase the role of ongoing research in maintaining a vigorous, stimulating academic and intellectual milieu that will inspire and prepare students and fellows to pursue research careers in environmental health sciences; and (4) provide support for pilot research. Support of pilot projects is intended to bolster the skills and abilities of investigators, to obtain preliminary data, and to publish in peer reviewed journals that can help ensure successful competition for traditional research grants and awards.

The purpose of this initiative is to form a cooperative program that will augment and strengthen the research infrastructure and research capabilities of faculty, students, and fellows at minority institutions by supporting the development of new, and/or the enhancement of ongoing, basic science and translational research that focuses on topics deemed to be of high priority and significance because of their critical importance to environmental health.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs.

2. Cost Sharing or Matching

Cost sharing is not required.

The most current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing.

3. Other-Special Eligibility Criteria
Not applicable

Section IV. Application and Submission Information

1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.

3. Submission Dates and Times
Applications must be received on or before the receipt date described below (Section IV.3.A). Submission times N/A.

3.A. Receipt, Review and Anticipated Start Dates

Letter of Intent Receipt Date: October 14, 2005
Application Receipt Date(s): November 16, 2005
Peer Review Date: March 2006
Council Review Date: May 2006
Earliest Anticipated Start Date: July 1, 2006

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed at the beginning of this document.

The letter of intent should be sent to:

Leroy Worth, Ph.D.
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O.B. 12233 (EC-30) 111 T.W. Alexander Drive (4401 Bldg)
Research Triangle Park, NC 27709
Telephone: (919) 541-0670
FAX: (919) 541-2503
Email: worth@niehs.nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant applications found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to:

Leroy Worth, Ph.D.
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O.B. 12233 (EC-30) 111 T.W. Alexander Drive (4401 Bldg)
Research Triangle Park, NC 27709
Telephone: (919) 541-0670
FAX: (919) 541-2503
Email: worth@niehs.nih.gov

Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf.

3.C. Application Processing

Applications must be received on or before the application receipt date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review. Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the NIEHS. Incomplete and non-responsive applications will not be reviewed.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.

4. Intergovernmental Review
This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

Pre-Award Costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or competing continuation award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or competing continuation award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.

6. Other Submission Requirements
Not applicable

Plan for Sharing Research Data

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.

Applicants requesting more than $500,000 in direct costs in any year of the proposed research must include a plan for sharing research data in their application. The funding organization will be responsible for monitoring the data sharing policy (http://grants.nih.gov/grants/policy/data_sharing).

The reasonableness of the data sharing plan or the rationale for not sharing research data may be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting.

Section V. Application Review Information

1. Criteria

The following will be considered in making funding decisions:

Only the review criteria described below will be considered in the review process.

Overall Program

Administrative and Planning Core

Research Program Development Core: Facility Core

Research Program Development Core: Scientific Projects

The review of the individual Research Projects is similar to the review of individual project grant applications (R01/R15) for the Research and Pilot Projects. These projects must have substantial scientific merit and, in essence, be of sufficient quality to be supported if they were submitted as individual projects. Research Project proposals that are not at this level of quality will not be funded. The review criteria are intended to focus more on the global picture of each project and the program overall rather than concentrating on the details of each experiment in their critiques.

2. Review and Selection Process

Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the National Institute of Environmental Health Sciences in accordance with the review criteria stated below.

As part of the initial merit review, all applications will:

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?

Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?

Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions will be assessed.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

2.C. Sharing Research Data

Data Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data may be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The funding organization will be responsible for monitoring the data sharing policy. http://grants.nih.gov/grants/policy/data_sharing.

2.D. Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

Program staff will be responsible for the administrative review of the plan for sharing research resources.

The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the awardee before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590). See Section VI.3. Reporting.

3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 14 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the business official.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Also Section IV.5. Funding Restrictions.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the Notice of Award. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).

3. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement.

Section VII. Agency Contacts

We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Frederick L. Tyson, Ph.D.
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
111 T.W. Alexander Drive, MD EC-21
P.O. Box 12233
Research Triangle Park, NC 27709
Telephone: (919) 541-0176
FAX: (919) 316-4606
Email: tyson2@niehs.nih.gov

2. Peer Review Contacts:

Leroy Worth, Jr., Ph.D.
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, MD EC-30
111 T.W. Alexander Drive
Research Triangle Park, NC 27709
Telephone: (919) 541-0670
FAX: (919) 541-2503
Email: worth@niehs.nih.gov

3. Financial or Grants Management Contacts:

Mr. Donald Ellis
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, MD EC-22
Telephone: (919) 541-1874
FAX: (919) 541-2860
Email: donaldellis@niehs.nih.gov

Section VIII. Other Information

Required Federal Citations

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review.

NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process please visit the NIH Public Access Policy Web site at http://www.nih.gov/about/publicaccess/ and view the Policy or other Resources and Tools including the Authors' Manual (http://www.nih.gov/about/publicaccess/publicaccess_Manual.htm).

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002 . The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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